Cough: A Typical Study
Background
A customer was conducting a phase IIb Clinical trial to investigate the efficacy and safety of an investigational medicinal product in patients with refractory and/or unexplained chronic cough. The customer wished to utilize the VitaloJAK® Cough Monitoring system that provides an objective measurement of cough, allowing home-based ambulatory recording over 24 hours with centralized, semi-automated analysis.
The Solution & Benefits
The scope of the study was reviewed and the following services were provided:
- Designated Vitalograph Web Portal configured to the specification of the study to give secure, restricted access to a centralized system for the collection and management of study data. This facilitated study management and oversight, patient and device management, centralized review and analysis capabilities.
- VitaloJAK cough monitors for each screened patient to capture the 24-hour cough recordings. The VitaloJAK device recorded sounds from the lungs and trachea through a chest contact sensor, as well as ambient sounds through a lapel microphone.
- Objective cough analysis by a team of expert cough analysts. The recordings were QC checked on receipt and then processed through the semi-automated cough analysis system developed by the internationally renowned cough researchers, Prof Jacky Smith, Dr Kevin McGuiness and Prof Ashley Woodcock, working at Manchester University NHS Foundation Trust (MFT).
- Centralized training was conducted at regional training sessions. This was supported by on-line access to training videos so that sites were able to refresh their knowledge at any time.
- A dedicated Project Manager and support team were allocated to the study to specify the study requirements, ensure the smooth running and quality of the study, whilst ensuring it was within budget.
- Data Management services for central collection of the study data, data cleaning, and secure data transfer at the agreed frequency.
- Reporting Services for generic and custom reports that allowed sites, CRAs, and sponsors, to review the progression of the study. These, alongside sponsor/vendor meetings, ensured clear communication and transparency of the study at all times so that informed decisions could be made regarding the studies in a timely manner.
- Site Support services to assist sites should they experience any technical difficulties they experienced with the Vitalograph system.
Summary
Vitalograph is renowned for working to high standards with quality devices and data. By using the VitaloJAK which is the only validated tool for objective assessment of cough in clinical trials and has an accuracy rating of 99.9% the sponsor was to generate reliable, quality data, for their trial’s primary and secondary outcome measures for cough.